Director Medical Device Manufacturing Operations at Castle Biosciences, Inc. in Phoenix, AZ, USA
- Company: Castle Biosciences, Inc.
- Location: Phoenix, AZ, USA
- Posted: Sep 17, 2026
- Type: Full-time
- Experience: 10+ years
Overview
Castle Biosciences Inc. is growing, and we are looking to hire a full-time Director Medical Device Manufacturing Operations working from our Phoenix, AZ office location, with a start date on or before October 1, 2026. Excellent Annual Salary + 35% Bonus Potential
Job description
- Castle Biosciences Inc. is growing, and we are looking to hire a full-time Director Medical Device Manufacturing Operations working from our Phoenix, AZ office location, with a start date on or before October 1, 2026.
- Excellent Annual Salary + 35% Bonus Potential
- 20 Accrued PTO Days Annually + 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options + Company HSA Contribution
- Company Stock Grant Upon Hire
Responsibilities
- We're building a brand-new medical device manufacturing operation and need an experienced leader to build it from the ground up. This Director-level role will own everything from facility startup and process validation, to team building and day-to-day operations. All within an FDA-regulated environment. It's a high-visibility opportunity for someone who thrives on creating something from scratch and wants to make a real impact at a growing diagnostics company. What you'll do: Lead the startup and commercial launch of Castle's new manufacturing facility; from equipment installation and process validation through first production runs; build and lead the manufacturing team, including hiring managers, supervisors, and technicians, and establishing the training and operational systems they need to succeed; own day-to-day manufacturing performance including safety, quality, delivery, and cost; while driving continuous improvement and ensuring ongoing FDA/ISO compliance.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Operations Management, or related field; advanced degree (MBA, MS Engineering, or related) preferred
- 10+ years of progressive manufacturing leadership experience in medical device, diagnostics, or biotechnology industries, with at least 5 years in director-level or equivalent roles
- Proven experience leading manufacturing startup operations, greenfield site launches, or significant facility expansions in FDA-regulated environments (21 CFR 820, ISO 13485, GMP)
- Strong understanding of process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems
- *Please see the full job description at the end of the job ad.
Skills
Required
- Manufacturing leadership
- Process validation (IQ/OQ/PQ)
- Equipment qualification
- Manufacturing documentation systems
- FDA/ISO compliance
- Continuous improvement
About Castle Biosciences, Inc.
At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.